FDA announces completion of first joint assessment with EMA in ICMRA pilot

The US Food and Drug Administration (FDA) on Friday announced the completion of its first collaborative assessment of a post-approval change for an oncology medicine with the European Medicines Agency (EMA) under the auspices of the International Coalition of Medicines Regulatory Authorities’ (ICMRA) joint review pilot program.

The sponsor sought to add new manufacturing and quality control sites, both of which were approved by the US and EU agencies. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) served as an observer.

The joint assessment teams “had a positive and productive experience, which produced a common set of highly aligned information requests and comments to the applicant,” said Theresa Mullin, associate center director for strategic initiatives in the Center for Drug Evaluation and Research (CDER) and Michael Kopcha, director of CDER’s Office of Pharmaceutical Quality (OPQ).

“Not only did this assessment result in an FDA approval, but there was no delay in the standard assessment timeline. In fact, it was completed under the four-month goal window for a standard manufacturing supplement assessment,” the officials said.

The EU approved the submission the same day as FDA. The agency said the joint assessment “received positive feedback” from industry.

In 2022, ICMRA announced it was seeking industry participants for two pilot programs, one exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and the other for reviewing postapproval changes. (RELATED: ICMRA explores hybrid inspections, postapproval changes with new pilots, Regulatory Focus 29 June 2022)

So far, ICMRA has accepted several proposals for the postapproval assessment pilot, including this recently completed FDA/EMA supplement assessment, said FDA. The other proposals cover the transfer of quality control sites for a biologic, the addition of a new drug active pharmaceutical ingredient manufacturing site, and the addition of a new finished drug product manufacturing site.

The hybrid inspection pilot has accepted two proposals, one for a pre-license inspection to support the drug substance manufacturing and quality control site transfer for a biologic, and the other for a preapproval inspection to support the addition of a drug manufacturing site. For both proposals, regulators will conduct a collaborative facility assessment using a combination of on-site inspection and remote assessment tools. A regulator from one country will perform an on-site inspection while other regulators will participate remotely.

The inspection pilot also “aims to identify the best virtual platforms and information technology” to enable on-site inspection and distant assessment. These pilots are due to be completed by early 2024.

The idea for the pilots emerged after a July 2021 meeting between ICMRA and industry representatives to explore ways to improve regulators’ understanding of specific challenges faced by manufacturers seeking to increase manufacturing capacity for COVID-19 therapeutics and vaccines.

The meeting identified the need for more convergence on chemistry, manufacturing and controls aspects between regions to allow faster supply of critical medicines to patients and to overcome travel logistical challenges created by the pandemic through use of hybrid inspections. (RELATED: ICMRA: Industry’s commitment to quality can facilitate regulatory flexibility, Regulatory Focus 12 October 2021).

FDA announcement

FDA announces completion of first joint assessment with EMA in ICMRA pilot

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